Study Results
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Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2010-04-30
2012-10-31
Brief Summary
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It has been observed that diabetic patients suffer more often from oral infections such as periodontal disease. Periodontal disease is an infectious-inflammatory disease that leads to destruction of the surrounding tissues of the tooth. It is proposed that the mechanisms responsible for systemic complication are implicated in the development of periodontal disease. This has been evaluated in studies where diabetic patients showed increased levels of inflammatory cytokines, subgingival bacteria and limited response to treatment. Its has also been suggested that established periodontitis in the diabetic patient leads to insulin resistance due to infection and liberation of cytokines from periodontal tissues and thus worsening the diabetic condition.
This study is aimed to establish the response to periodontal treatment with antibiotics and the kinetics of glucose levels in diabetic patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Group IP1
Scaling and root planing plus placebo
Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days
Group IP2
Scaling and root planing plus azythromycin
Single session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
Group IP3
Prophylaxis plus azythromycin
Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
Interventions
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Scaling and root planing plus placebo
Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days
Scaling and root planing plus azythromycin
Single session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
Prophylaxis plus azythromycin
Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
Eligibility Criteria
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Inclusion Criteria
* Voluntary participation and signed informed consent.
* Confirmed type I and II diabetes.
* At least 10 teeth present in mouth.
Exclusion Criteria
* pregnant women.
* Antibiotic consumption 3 months before inclusion.
* HIV positive or AIDS.
* Allergic reactions to macrolides and specifically to azythromycin.
* Periodontal treatment 6 months before inclusion.
18 Years
ALL
No
Sponsors
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Colgate Palmolive
INDUSTRY
Universidad de Antioquia
OTHER
Responsible Party
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Javier Enrique Botero
Assistant Professor
Principal Investigators
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Javier E Botero, PhD
Role: STUDY_DIRECTOR
Universidad de Antioquia, School of dentistry
Fanny L Yepes, DDS
Role: PRINCIPAL_INVESTIGATOR
Universidad de Antioquia, School of dentistry
Locations
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Universidad de Antioquia, School of dentistry
Medellín, Antioquia, Colombia
Countries
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References
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Dandona P, Chaudhuri A, Ghanim H, Mohanty P. Proinflammatory effects of glucose and anti-inflammatory effect of insulin: relevance to cardiovascular disease. Am J Cardiol. 2007 Feb 19;99(4A):15B-26B. doi: 10.1016/j.amjcard.2006.11.003. Epub 2006 Dec 27.
Emrich LJ, Shlossman M, Genco RJ. Periodontal disease in non-insulin-dependent diabetes mellitus. J Periodontol. 1991 Feb;62(2):123-31. doi: 10.1902/jop.1991.62.2.123.
Novak MJ, Potter RM, Blodgett J, Ebersole JL. Periodontal disease in Hispanic Americans with type 2 diabetes. J Periodontol. 2008 Apr;79(4):629-36. doi: 10.1902/jop.2008.070442.
Mealey BL, Rose LF. Diabetes mellitus and inflammatory periodontal diseases. Curr Opin Endocrinol Diabetes Obes. 2008 Apr;15(2):135-41. doi: 10.1097/MED.0b013e3282f824b7.
Ryan ME, Carnu O, Kamer A. The influence of diabetes on the periodontal tissues. J Am Dent Assoc. 2003 Oct;134 Spec No:34S-40S. doi: 10.14219/jada.archive.2003.0370.
Sammalkorpi K. Glucose intolerance in acute infections. J Intern Med. 1989 Jan;225(1):15-9. doi: 10.1111/j.1365-2796.1989.tb00030.x.
Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, Knowler WC, Pettitt DJ. Severe periodontitis and risk for poor glycemic control in patients with non-insulin-dependent diabetes mellitus. J Periodontol. 1996 Oct;67(10 Suppl):1085-93. doi: 10.1902/jop.1996.67.10s.1085.
Garcia R. Periodontal treatment could improve glycaemic control in diabetic patients. Evid Based Dent. 2009;10(1):20-1. doi: 10.1038/sj.ebd.6400633.
Dag A, Firat ET, Arikan S, Kadiroglu AK, Kaplan A. The effect of periodontal therapy on serum TNF-alpha and HbA1c levels in type 2 diabetic patients. Aust Dent J. 2009 Mar;54(1):17-22. doi: 10.1111/j.1834-7819.2008.01083.x.
Madden TE, Herriges B, Boyd LD, Laughlin G, Chiodo G, Rosenstein D. Alterations in HbA1c following minimal or enhanced non-surgical, non-antibiotic treatment of gingivitis or mild periodontitis in type 2 diabetic patients: a pilot trial. J Contemp Dent Pract. 2008 Jul 1;9(5):9-16.
Ernst EJ, Klepser ME, Klepser TB, Nightingale CH, Hunsicker LG. Comparison of the serum and intracellular pharmacokinetics of azithromycin in healthy and diabetic volunteers. Pharmacotherapy. 2000 Jun;20(6):657-61. doi: 10.1592/phco.20.7.657.35176.
Other Identifiers
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020-2009
Identifier Type: -
Identifier Source: org_study_id
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